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Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

Primary Purpose

Meningococcal Disease

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
MenACWY-CRM
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Toddlers, Children, Persistence, Boost

Eligibility Criteria

22 Months - 45 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children eligible to be enrolled in the study were those

  • whose parents provide written informed consent;
  • were in generally good health based on the clinical judgment of the investigators;
  • subjects were 22-45 months of age at the time of enrollment into V59P22E1;
  • subject who had participated in the parent V59P22 study.

Exclusion Criteria:

Main exclusion criteria:

  • Subjects with serious, acute, or chronic illnesses
  • Subjects who had received any other licensed vaccines within 28 days (Exception: Influenza vaccine was allowed up to 14 days prior to and no less than 14 days after the study immunization) prior to enrolment and any study visit
  • Subjects who had received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.

Sites / Locations

  • Dr. Johannes Kandzora and Dr. Kathrin Kandzora
  • Bogda-Maria Kniese,
  • Dr Goertz Martin Kimmig
  • Dr med Walter Otto
  • Dr med Kerstin Pscherer
  • Dr Renate Mangelsdorf-Taxis
  • Dr. Christoph Wittermann
  • Ute Jessat
  • Dr med Luise Schroeter
  • Dr med Ulrich Pfletschinger
  • Dr Lothar Maurer

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MenACWY (2 primary + 1 booster dose)

MenACWY (1 primary + 1 booster dose)

MenC (1 primary dose)+MenACWY (1 booster dose)

Arm Description

Subjects who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.

Subjects who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.

Subjects who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.

Outcomes

Primary Outcome Measures

Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination
The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination
The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination
The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine
The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y

Secondary Outcome Measures

Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination
The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination
The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.

Full Information

First Posted
April 29, 2011
Last Updated
May 17, 2018
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01345721
Brief Title
Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
Official Title
A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease
Keywords
Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Toddlers, Children, Persistence, Boost

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MenACWY (2 primary + 1 booster dose)
Arm Type
Experimental
Arm Description
Subjects who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
Arm Title
MenACWY (1 primary + 1 booster dose)
Arm Type
Experimental
Arm Description
Subjects who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
Arm Title
MenC (1 primary dose)+MenACWY (1 booster dose)
Arm Type
Experimental
Arm Description
Subjects who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM
Primary Outcome Measure Information:
Title
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
Description
The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)
Time Frame
From 13-33 months post last vaccination in parent study (V59P22)
Title
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination
Description
The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.
Time Frame
1 month post booster
Title
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination
Description
The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.
Time Frame
1 month post booster vaccination
Title
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination
Description
The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y
Time Frame
1 month after vaccination
Title
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine
Description
The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y
Time Frame
1 month post vaccination
Secondary Outcome Measure Information:
Title
Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
Description
The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Time Frame
From 13-33 months post last vaccination in parent study (V59P22)
Title
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Description
Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y
Time Frame
1 month post vaccination
Title
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Description
Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Time Frame
1 month post vaccination
Title
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination
Description
The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.
Time Frame
Day 1-7 after vaccination
Title
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination
Description
The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.
Time Frame
Day 1-28 after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Months
Maximum Age & Unit of Time
45 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children eligible to be enrolled in the study were those whose parents provide written informed consent; were in generally good health based on the clinical judgment of the investigators; subjects were 22-45 months of age at the time of enrollment into V59P22E1; subject who had participated in the parent V59P22 study. Exclusion Criteria: Main exclusion criteria: Subjects with serious, acute, or chronic illnesses Subjects who had received any other licensed vaccines within 28 days (Exception: Influenza vaccine was allowed up to 14 days prior to and no less than 14 days after the study immunization) prior to enrolment and any study visit Subjects who had received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.
Facility Information:
Facility Name
Dr. Johannes Kandzora and Dr. Kathrin Kandzora
City
Am Teich 11, Neumuenster
ZIP/Postal Code
24534
Country
Germany
Facility Name
Bogda-Maria Kniese,
City
Boyneburgstr 7, Eschwege
ZIP/Postal Code
37269
Country
Germany
Facility Name
Dr Goertz Martin Kimmig
City
GroBbottwarer Str 47, Oberstenfeld
ZIP/Postal Code
71720
Country
Germany
Facility Name
Dr med Walter Otto
City
Heinrichstrasse 16 A, Fulda
ZIP/Postal Code
36037
Country
Germany
Facility Name
Dr med Kerstin Pscherer
City
Hellersdorfer Str 237, Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Dr Renate Mangelsdorf-Taxis
City
Kirchstrasse 2, Bonnigheim
ZIP/Postal Code
74357
Country
Germany
Facility Name
Dr. Christoph Wittermann
City
Murnauer Str 3, Weilheim
ZIP/Postal Code
82362
Country
Germany
Facility Name
Ute Jessat
City
Rathausstr 6, Gluecksburg
ZIP/Postal Code
24960
Country
Germany
Facility Name
Dr med Luise Schroeter
City
Schoenwalder Str 28, Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Dr med Ulrich Pfletschinger
City
Stuttgarter Strasse 74, Stuttgart Feuerbach
ZIP/Postal Code
70469
Country
Germany
Facility Name
Dr Lothar Maurer
City
Welschgasse 39, Frankenthal
ZIP/Postal Code
67227
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33325757
Citation
Giuliani MM, Biolchi A, Keshavan P, Moriondo M, Tomei S, Santini L, Mori E, Brozzi A, Bodini M, Nieddu F, Ricci S, Mzolo T, Costantini M, Azzari C, Pellegrini M. Bactericidal antibodies against hypervirulent Neisseria meningitidis C field strains following MenC-CRM or MenACWY-CRM priming and MenACWY-CRM booster in children. Hum Vaccin Immunother. 2021 May 4;17(5):1442-1449. doi: 10.1080/21645515.2020.1833578. Epub 2020 Dec 16.
Results Reference
derived

Learn more about this trial

Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

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